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Tu1077 Effect of Mosapride on Ineffective Esophageal Motility in Patients With Erosive Gastroesophageal Reflux Disease
Tu1074
somewhat; 3 = moderately; 4 = a good deal; 5 = a great deal; 6 = a very great deal”. This question was asked separately for “all of your symptoms of IBS” and for “your specific symptom of bloating”. Adequate relief was defined as: (a) 0=not at all or 1=hardly at least 50% of the days in a given week; or, (b) 0=not at all, 1=hardly, or 2=somewhat for 100% of the days in a given week. Responders were defined as patients with adequate relief for 2/4 weeks after completing 14 days of treatment. Results: Among the 1258 patients in the intention-to-treat analysis, patients with adequate relief in both treatment weeks (n = 295) were less frequent than patients without relief in both weeks (n = 963). Results are listed in Table 1. Conclusions: In TARGET 1 and 2, RFX-treated patients were more likely than PLC-treated patients to get sustained relief of daily global IBS symptoms and bloating, regardless of achieving adequate relief of global IBS symptoms during both weeks of treatment. Thus, patients who do not achieve global IBS relief during both weeks of RFX therapy were still more likely to be responders compared to similar PLC-treated patients. Adequate relief of global IBS symptoms during both weeks of RFX-treatment predicted higher responder rates during the four weeks post-treatment. Percentage of Responders
AGA Abstracts
Videocapsule Versus Enteroscopy in Patients With Obscure GI Bleeding: Results of a Randomized Controlled Trial Alan N. Barkun, Yen-I Chen, Kevin Waschke, Pascal Burtin, Josee Parent, Serge Mayrand, Carlo A. Fallone, Gilles Jobin, Myriam Martel Background: Videocapsule endoscopy (VCE), when compared to enteroscopy (E), is associated with increased detection of mucosal lesions in obscure gastrointestinal bleeding (OGB). However, few randomized trials have compared these two modalities, and data on clinical relevance are lacking. The aim of this study was to compare VCE with E in terms of diagnostic yield and subsequent clinical outcome. Methods: We randomly allocated adult patients with occult bleeding (iron deficiency anemia >6 months needing blood transfusion or iron supplementation with repeated positive stool occult blood testing) or overt bleeding (≥1episode of melena/hematochezia within 7 days of presentation and a hemoglobin drop ≥15 g/dL) to VCE or E after a negative initial work-up (single or repeated gastroscopy and colonoscopy examinations with or without small bowel radiology). The main outcomes were recurrence and persistence of bleeding using standardized criteria defined a priori over 1year. Crossovers were permitted after the main outcome was reached. Results: 79 patients (68.5±14.5yrs, 36.7% female) were included over a 5-year period. 40 subjects were allocated to VCE and 39 to E (of push type). Overall, 76.0% presented with overt bleeding. At baseline, 24.1% were taking ASA, 11.4% an anticoagulant, and 2.5% an NSAID; 76.7% of patients had a nuclear scan, and 37.0% an angiography. No significant differences were noted in baseline characteristics between the two groups. At least one lesion was detected in 72.5% of the VCE group compared to 48.7% in the E group (p=0.03); they were believed to be the source of bleeding in 79.3% and 35.0% (p=0.002), respectively. Although detection rates were similar for gastric and duodenal findings, VCE performed better in the first and second parts of the jejunum (50% vs. 10.3% P=0.0001, and 40% vs. 2.6% P<0.0001). No disparities were observed in terms of the nature of the lesions found between the two modalities. Mean duration of follow-up was 289.0±118.8 days, with 50.0% requiring a blood transfusion (42.5% VCE vs. 57.9% E, with a mean of 2.9 ± 5.0 units (VCE: 2.8±4.3 units vs. E: 3.0±5.6 units, P=NS)). Hospitalization for bleeding or continued bleeding occurred in 40.0% of VCE and in 53.9% of E patients (P=NS) (mean stay: 11.0±11.9 and 18.5±28.2 days respectively, P=NS). Crossovers occurred more frequently from E to VCE than from VCE to E (48.7% vs. 22.5%, P=0.015). Conclusions: VCE increases diagnostic yield in OGB when compared to E, especially when the bleeding source is in the jejunum. However, subsequent impact on clinical care was not significantly better in this trial although trends favored the VCE group. More crossovers were noted from E to VCE than conversely. Overall, our data support the use of VCE over E following an initial work-up in patients with OGB.
* P-value <0.05 vs placebo Tu1077 Effect of Mosapride on Ineffective Esophageal Motility in Patients With Erosive Gastroesophageal Reflux Disease Margarita M. Hernandez, Mauricio Sepulveda, Diana Torres, Alberto Rodriguez, Jaime Alvarado, Albis Hani Background: Ineffective esophageal motility (IEM) is an esophageal motility disorder associated with Gastroesophageal Reflux Disease (GERD). Some of the symptoms reported by patients with GERD may be associated with this motor disorder. Mosapride is an agonist of the serotonin receptor type 4 (5-HT(4)R) with procinetic effect in the superior gastrointestinal tract. We proposed that in patients with GERD associated with IEM, Mosapride can reverse motor impairment and have a beneficial effect in symptomatic improvement. Materials and methods: We performed a clinical trial, controlled, randomized, double-blind study in 44 patients that were diagnosed with peptic esophagitis (PE) and endoscopic manometry IEM confirmed using the criteria of the Castell's classification of esophageal motility disorders. Were randomized to two groups, the intervention group received omeprazole 40 mg daily and mosapride 5 mg tid over 8 weeks. The control group received omeprazole 40 mg daily plus placebo during the same period. After treatment, patients were evaluated with esophageal manometry, upper endoscopy and esophageal pH monitoring. On admission, at week 4 and the end of treatment were followed for symptoms using the RDQ survey. Results: Of the 44 patients, 33 patients completed the study. The demographic and clinical characteristics in symptoms, severity of oesophagitis and manometric findings at baseline were similar in both groups. At 8 weeks of treatment, the resolution of symptoms was 94% in the intervention group and 93% in the control group. Observed resolution manometric IEM findings in 35% of patients in the intervention group and 37% control. Of the 11 patients with ineffective esophageal motility persisted in the intervention group, 4 (23.53%) was documented esophageal pH monitoring positive for acid reflux, compared with 3 patients (18.75%) in the control group. None of the small differences found in the two groups were statistically significant. Conclusion: In our study we did not find the benefit of using mosapride in the resolution of symptoms and manometric criteria of IEM in patients with erosive GERD. We are aware of the sample size limitation, which decrease the power to find differences between the two groups, so it is important to continue the study in order to have a greater number of patients to assess the usefulness of Mosapride in this pathology.
Tu1075 A Prospective Randomized Trial With 7-Day Nitrofurantoin-Containing Regime for Third-Line Helicobacter pylori Eradication Ivan F. Hung, Sze Hang Kevin Liu, Wai keung Leung Background: Limited treatment options are available for Helicobacter pylori infected patients who failed to achieve eradication after the first line clarithromycin containing triple therapy and second line quadruple therapy. The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori eradication with a nitrofurantoin-containing regime against repeating the quadruple therapy. Method: This is a single center prospective randomized, open-label, parallel trial performed between March 2008 and August 2011. Patients who previously received and failed the first line clarithromycin triple therapy and the second line quadruple therapy were recruited. Patients were randomized to receive either a 7-day NITRO (esomeprazole 20mg twice daily, nitrofurantoin 100mg four times daily, moxifloxacin 400mg daily and ursodeoxycholic acid 250mg three times daily), or a 7-day QUAD (esomeprazole 20mg twice daily, bismuth subcitrate 120mg four times daily, tetracycline 500mg four times daily and metronidazole 400mg four times daily) as control. Eradication of H. pylori was confirmed by 13C-urea breath test 8 weeks after the last day of treatment. Results: 155 patients were recruited and 9 patients did not complete the treatment. The intentionto-treat (ITT) eradication rates in the NITRO group (n=77) and the QUAD group (n=78) were 67.5% and 59% respectively (P=0.32), and 69.4% and 60.8% (P=0.301) in the per protocol (PP) analysis, respectively. None of the patients developed major side effects from either regime. Conclusions: The nitrofurantoin-containing regime is an effective third line eradication treatment for patients who developed resistant H. pylori infection.
Tu1078 The Two Weeks Sequential Therapy and the Concomitant Therapy for Helicobacter pylori Eradication Were Effective as a First Line Therapy in Korea: A Preliminary Report Chiun Choi, Dong-ho Lee, Ilyoung Chon, Hyun kyung Park
Tu1076
Backgrounds and Aims: The eradication rate of proton-pump inhibitor (PPI)-based triple therapy for Helicobacter pylori has decreased due to increasing antibiotics resistance. Recently, the sequential therapy and the concomitant therapy is tried to overcome antibiotics resistance and have produced good outcomes in many countries. The aim of this study was to assess the efficacy of those therapies in Korea. Materials and Methods: A total 63 patients with proven H. pylori infection were enrolled in this study. Twenty seven patients (mean age 58.0±12.5, male 33.3%) received the sequential therapy (20mg of rabeprazole and 1g of amoxicillin, twice daily for the first 7days, followed by 20mg of rabeprazole, 500mg of clarithromycin, and 500mg of metronidazole, twice daily for the remaining 7days) and the other 36 patients (mean age 54.2±11.6, male 55.6%) took the concomitant therapy (20mg of rabeprazole, 1g of amoxicillin, 500mg of clarithrymcyin, and 500mg of metronidazole, twice a day for 14days). Successfulness of eradication was evaluated by the 13C-urea breath test at least 4 weeks later after end of treatment. Result: The eradication rate of the sequential and the concomitant therapies was 85.2% (23/27) and 88.9% (32/36) by intention-to-treat analysis, 91.7% (22/24) and 88.6% (31/35) by per-protocol analysis, but there was no difference statistically (p=0.662 and p=0.699). The adverse rate was 57.7% (15/26) in sequential therapy group and 54.3% (19/35) in concomitant therapy group, also there was no difference (p=0.791), and almost all patients were well tolerable to each therapies. Conclusion: Those therapies were effective to eradicate Helicobacter pylori in Korea as a first line therapy. They had relatively higher adverse rate, but those all were minor problems, both therapies were well tolerated.
Predictive Value of Adequate Relief of Global IBS Symptoms During First Two Weeks of Rifaximin use on Subsequent Relief of Daily IBS Symptoms and Daily Bloating Symptoms Philip S. Schoenfeld, Mark Pimentel, Tina Wu, Enoch Bortey, William P. Forbes Introduction: Rifaximin (RFX) 550 mg tid X 14 days demonstrated adequate relief of global IBS symptoms and bloating over placebo in patients with irritable bowel syndrome without constipation (non-C IBS) based upon two randomized double-blind, placebo-controlled trials (RCTs). The impact of adequate relief of global IBS symptoms during the two weeks when patients used RFX or PLC on post-treatment symptom improvement is unclear. Aim: To examine the impact of adequate relief of global IBS symptoms during two weeks of RFX use on post-treatment improvement in global IBS symptoms and bloating. Methods: In these RCTs (TARGET 1 and 2), adequate relief of global IBS symptoms was assessed weekly. For this sub-group analysis, results are reported for two groups: (a) patients who had adequate relief of global IBS symptoms during both weeks of treatment with RFX or PLC; and, (b) patients who did not have adequate relief of global IBS symptoms during both weeks. Also, for this sub-group analysis, daily assessment of global IBS symptoms and bloating for 4 weeks after completing RFX or PLC treatment is examined. Adequate relief of symptoms was addressed with this daily question: “In regards to your symptoms; on a scale of 0-6, how bothersome were your symptoms today? 0=not at all; 1 = hardly; 2 =
AGA Abstracts
S-740
somewhat; 3 = moderately; 4 = a good deal; 5 = a great deal; 6 = a very great deal”. This question was asked separately for “all of your symptoms of IBS” and for “your specific symptom of bloating”. Adequate relief was defined as: (a) 0=not at all or 1=hardly at least 50% of the days in a given week; or, (b) 0=not at all, 1=hardly, or 2=somewhat for 100% of the days in a given week. Responders were defined as patients with adequate relief for 2/4 weeks after completing 14 days of treatment. Results: Among the 1258 patients in the intention-to-treat analysis, patients with adequate relief in both treatment weeks (n = 295) were less frequent than patients without relief in both weeks (n = 963). Results are listed in Table 1. Conclusions: In TARGET 1 and 2, RFX-treated patients were more likely than PLC-treated patients to get sustained relief of daily global IBS symptoms and bloating, regardless of achieving adequate relief of global IBS symptoms during both weeks of treatment. Thus, patients who do not achieve global IBS relief during both weeks of RFX therapy were still more likely to be responders compared to similar PLC-treated patients. Adequate relief of global IBS symptoms during both weeks of RFX-treatment predicted higher responder rates during the four weeks post-treatment. Percentage of Responders
AGA Abstracts
Videocapsule Versus Enteroscopy in Patients With Obscure GI Bleeding: Results of a Randomized Controlled Trial Alan N. Barkun, Yen-I Chen, Kevin Waschke, Pascal Burtin, Josee Parent, Serge Mayrand, Carlo A. Fallone, Gilles Jobin, Myriam Martel Background: Videocapsule endoscopy (VCE), when compared to enteroscopy (E), is associated with increased detection of mucosal lesions in obscure gastrointestinal bleeding (OGB). However, few randomized trials have compared these two modalities, and data on clinical relevance are lacking. The aim of this study was to compare VCE with E in terms of diagnostic yield and subsequent clinical outcome. Methods: We randomly allocated adult patients with occult bleeding (iron deficiency anemia >6 months needing blood transfusion or iron supplementation with repeated positive stool occult blood testing) or overt bleeding (≥1episode of melena/hematochezia within 7 days of presentation and a hemoglobin drop ≥15 g/dL) to VCE or E after a negative initial work-up (single or repeated gastroscopy and colonoscopy examinations with or without small bowel radiology). The main outcomes were recurrence and persistence of bleeding using standardized criteria defined a priori over 1year. Crossovers were permitted after the main outcome was reached. Results: 79 patients (68.5±14.5yrs, 36.7% female) were included over a 5-year period. 40 subjects were allocated to VCE and 39 to E (of push type). Overall, 76.0% presented with overt bleeding. At baseline, 24.1% were taking ASA, 11.4% an anticoagulant, and 2.5% an NSAID; 76.7% of patients had a nuclear scan, and 37.0% an angiography. No significant differences were noted in baseline characteristics between the two groups. At least one lesion was detected in 72.5% of the VCE group compared to 48.7% in the E group (p=0.03); they were believed to be the source of bleeding in 79.3% and 35.0% (p=0.002), respectively. Although detection rates were similar for gastric and duodenal findings, VCE performed better in the first and second parts of the jejunum (50% vs. 10.3% P=0.0001, and 40% vs. 2.6% P<0.0001). No disparities were observed in terms of the nature of the lesions found between the two modalities. Mean duration of follow-up was 289.0±118.8 days, with 50.0% requiring a blood transfusion (42.5% VCE vs. 57.9% E, with a mean of 2.9 ± 5.0 units (VCE: 2.8±4.3 units vs. E: 3.0±5.6 units, P=NS)). Hospitalization for bleeding or continued bleeding occurred in 40.0% of VCE and in 53.9% of E patients (P=NS) (mean stay: 11.0±11.9 and 18.5±28.2 days respectively, P=NS). Crossovers occurred more frequently from E to VCE than from VCE to E (48.7% vs. 22.5%, P=0.015). Conclusions: VCE increases diagnostic yield in OGB when compared to E, especially when the bleeding source is in the jejunum. However, subsequent impact on clinical care was not significantly better in this trial although trends favored the VCE group. More crossovers were noted from E to VCE than conversely. Overall, our data support the use of VCE over E following an initial work-up in patients with OGB.
* P-value <0.05 vs placebo Tu1077 Effect of Mosapride on Ineffective Esophageal Motility in Patients With Erosive Gastroesophageal Reflux Disease Margarita M. Hernandez, Mauricio Sepulveda, Diana Torres, Alberto Rodriguez, Jaime Alvarado, Albis Hani Background: Ineffective esophageal motility (IEM) is an esophageal motility disorder associated with Gastroesophageal Reflux Disease (GERD). Some of the symptoms reported by patients with GERD may be associated with this motor disorder. Mosapride is an agonist of the serotonin receptor type 4 (5-HT(4)R) with procinetic effect in the superior gastrointestinal tract. We proposed that in patients with GERD associated with IEM, Mosapride can reverse motor impairment and have a beneficial effect in symptomatic improvement. Materials and methods: We performed a clinical trial, controlled, randomized, double-blind study in 44 patients that were diagnosed with peptic esophagitis (PE) and endoscopic manometry IEM confirmed using the criteria of the Castell's classification of esophageal motility disorders. Were randomized to two groups, the intervention group received omeprazole 40 mg daily and mosapride 5 mg tid over 8 weeks. The control group received omeprazole 40 mg daily plus placebo during the same period. After treatment, patients were evaluated with esophageal manometry, upper endoscopy and esophageal pH monitoring. On admission, at week 4 and the end of treatment were followed for symptoms using the RDQ survey. Results: Of the 44 patients, 33 patients completed the study. The demographic and clinical characteristics in symptoms, severity of oesophagitis and manometric findings at baseline were similar in both groups. At 8 weeks of treatment, the resolution of symptoms was 94% in the intervention group and 93% in the control group. Observed resolution manometric IEM findings in 35% of patients in the intervention group and 37% control. Of the 11 patients with ineffective esophageal motility persisted in the intervention group, 4 (23.53%) was documented esophageal pH monitoring positive for acid reflux, compared with 3 patients (18.75%) in the control group. None of the small differences found in the two groups were statistically significant. Conclusion: In our study we did not find the benefit of using mosapride in the resolution of symptoms and manometric criteria of IEM in patients with erosive GERD. We are aware of the sample size limitation, which decrease the power to find differences between the two groups, so it is important to continue the study in order to have a greater number of patients to assess the usefulness of Mosapride in this pathology.
Tu1075 A Prospective Randomized Trial With 7-Day Nitrofurantoin-Containing Regime for Third-Line Helicobacter pylori Eradication Ivan F. Hung, Sze Hang Kevin Liu, Wai keung Leung Background: Limited treatment options are available for Helicobacter pylori infected patients who failed to achieve eradication after the first line clarithromycin containing triple therapy and second line quadruple therapy. The aim of this randomized trial is to compare the efficacy and tolerability of H. pylori eradication with a nitrofurantoin-containing regime against repeating the quadruple therapy. Method: This is a single center prospective randomized, open-label, parallel trial performed between March 2008 and August 2011. Patients who previously received and failed the first line clarithromycin triple therapy and the second line quadruple therapy were recruited. Patients were randomized to receive either a 7-day NITRO (esomeprazole 20mg twice daily, nitrofurantoin 100mg four times daily, moxifloxacin 400mg daily and ursodeoxycholic acid 250mg three times daily), or a 7-day QUAD (esomeprazole 20mg twice daily, bismuth subcitrate 120mg four times daily, tetracycline 500mg four times daily and metronidazole 400mg four times daily) as control. Eradication of H. pylori was confirmed by 13C-urea breath test 8 weeks after the last day of treatment. Results: 155 patients were recruited and 9 patients did not complete the treatment. The intentionto-treat (ITT) eradication rates in the NITRO group (n=77) and the QUAD group (n=78) were 67.5% and 59% respectively (P=0.32), and 69.4% and 60.8% (P=0.301) in the per protocol (PP) analysis, respectively. None of the patients developed major side effects from either regime. Conclusions: The nitrofurantoin-containing regime is an effective third line eradication treatment for patients who developed resistant H. pylori infection.
Tu1078 The Two Weeks Sequential Therapy and the Concomitant Therapy for Helicobacter pylori Eradication Were Effective as a First Line Therapy in Korea: A Preliminary Report Chiun Choi, Dong-ho Lee, Ilyoung Chon, Hyun kyung Park
Tu1076
Backgrounds and Aims: The eradication rate of proton-pump inhibitor (PPI)-based triple therapy for Helicobacter pylori has decreased due to increasing antibiotics resistance. Recently, the sequential therapy and the concomitant therapy is tried to overcome antibiotics resistance and have produced good outcomes in many countries. The aim of this study was to assess the efficacy of those therapies in Korea. Materials and Methods: A total 63 patients with proven H. pylori infection were enrolled in this study. Twenty seven patients (mean age 58.0±12.5, male 33.3%) received the sequential therapy (20mg of rabeprazole and 1g of amoxicillin, twice daily for the first 7days, followed by 20mg of rabeprazole, 500mg of clarithromycin, and 500mg of metronidazole, twice daily for the remaining 7days) and the other 36 patients (mean age 54.2±11.6, male 55.6%) took the concomitant therapy (20mg of rabeprazole, 1g of amoxicillin, 500mg of clarithrymcyin, and 500mg of metronidazole, twice a day for 14days). Successfulness of eradication was evaluated by the 13C-urea breath test at least 4 weeks later after end of treatment. Result: The eradication rate of the sequential and the concomitant therapies was 85.2% (23/27) and 88.9% (32/36) by intention-to-treat analysis, 91.7% (22/24) and 88.6% (31/35) by per-protocol analysis, but there was no difference statistically (p=0.662 and p=0.699). The adverse rate was 57.7% (15/26) in sequential therapy group and 54.3% (19/35) in concomitant therapy group, also there was no difference (p=0.791), and almost all patients were well tolerable to each therapies. Conclusion: Those therapies were effective to eradicate Helicobacter pylori in Korea as a first line therapy. They had relatively higher adverse rate, but those all were minor problems, both therapies were well tolerated.
Predictive Value of Adequate Relief of Global IBS Symptoms During First Two Weeks of Rifaximin use on Subsequent Relief of Daily IBS Symptoms and Daily Bloating Symptoms Philip S. Schoenfeld, Mark Pimentel, Tina Wu, Enoch Bortey, William P. Forbes Introduction: Rifaximin (RFX) 550 mg tid X 14 days demonstrated adequate relief of global IBS symptoms and bloating over placebo in patients with irritable bowel syndrome without constipation (non-C IBS) based upon two randomized double-blind, placebo-controlled trials (RCTs). The impact of adequate relief of global IBS symptoms during the two weeks when patients used RFX or PLC on post-treatment symptom improvement is unclear. Aim: To examine the impact of adequate relief of global IBS symptoms during two weeks of RFX use on post-treatment improvement in global IBS symptoms and bloating. Methods: In these RCTs (TARGET 1 and 2), adequate relief of global IBS symptoms was assessed weekly. For this sub-group analysis, results are reported for two groups: (a) patients who had adequate relief of global IBS symptoms during both weeks of treatment with RFX or PLC; and, (b) patients who did not have adequate relief of global IBS symptoms during both weeks. Also, for this sub-group analysis, daily assessment of global IBS symptoms and bloating for 4 weeks after completing RFX or PLC treatment is examined. Adequate relief of symptoms was addressed with this daily question: “In regards to your symptoms; on a scale of 0-6, how bothersome were your symptoms today? 0=not at all; 1 = hardly; 2 =
AGA Abstracts
S-740